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Mesoblast Limited (MEOBF)

Other OTC - Other OTC Delayed Price. Currency in USD
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0.48000.0000 (0.00%)
At close: 11:37AM EDT
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  • S
    Steve S
    Headed In wrong direction .
  • v
    vasav963
    Quiet and down every day. 😡 Only news I have recently is the request I received in the mail for the class action suit.

    Tick...tock....tick....tock.... come on MESO and questionable FDA
    ...(still thinking 9 to 1) and here we are. 🤨

    As always, GLTA....
  • C
    CavScout1969
    Latest class action has a proposed $2 mil settlement against the Defendents, certain current and former MESO execs. Funny I got a card in the mail to file a claim even though I made good money trading this from Dec. 2018 to Oct. 2020, the time period listed in the suit.
  • F
    Frank B
    Just hoping we’re not all dead before this company gets some traction
  • L
    LongStock
    Dr Itescu mention again during the KOL meeting that they are in "discussions" for partnerships. Notice the plura pronounciation. CHF, Crohns, ARDS and CLBP are all too big for Mesoblast to "go-it-alone"

    These are all billion dollar indications and each could fetch $150 million in upfront cash plus a 50/50 split in profits but in my opinion that's not what's being negotiated. The negotiations probably centers more around getting a real commitment and preventing non-action. Many big pharmas have financial reasons to sidetrack Mesoblast products. That's just the way it is with big pharma, Mesoblast has to be very careful.
  • s
    stephen
    Something is slowly turning up heat.... from ice cooled to luke warm.... don't miss out ...jump in before it gets to hot
  • J
    Josephine
    SO predictable, 5 sh @ 2.40.
  • J
    Josephine
    Wonder, if ever, the deadbeats will give up trying to drive this further down?? Got to be
    desperation to be selling at this price, or someone with the wherewithall to make it happen at
    little cost to themselves to serve their agenda. Can only hope they get a bomb dropped on
    them that they can't escape.
  • s
    stephen
    Dachopper on HC sum things nicely.....

    Interesting quarterly update to say the least.

    GvHD - The company has now given an indication of when it will submit the BLA exactly stating " next quarter" or Q3 2022. Not only that, Dr Rose explained what it is exactly that they have been waiting for and completing.
    He admitted that there were issues with the previous potency assay used, and that it had ben replaced with a new anti-T cell potency assay. He said the assay can predict patient outcomes based on disease severity, stage or map score... BIG Tick
    Si mentioned just last week the Lonza manufacturing facility used for the cells underwent a mock inspection by a 3rd party ( virtual and in person ) , and passed. This is needed since the FDA will inspect prior to BLA granting.
    Dr Rose mentioned they are now in the process of validating supply chain issues with regards to potency assay ( I presume this is the new potency assay ) testing kits, which explains the delay until Q3 submission as they would require the results from the testing first.
    He believe the totality of the evidence is there... the company has addressed and in doing so improved the company's manufacturing, and that they all believe that this should be approved as CRL items are addressed. Si also mentioned it was incredibly importantly that the company " get it done correctly", and as such they are taking their time.

    ARDS - My guess in the other thread about ARDS, sounds as if it is on the right track. Si confirmed they are looking at another COVID ARDS trial in younger people ( probably the under 65 sub group ), and that they are also discussing other disease caused ARDS with investigators such as influenza. It may not end up being " All Cause ARDS" but it sounds to me at the least it will be expanded into other disease / virus / bacteria caused ARDS.
    The trial will not commence until the Remestemcel potency assays are " In Place"
    I think, since the restriction was originally made by the FDA, it is going to be at the whim of the FDA as to exactly what and when " in place" is. It could be when CBER do the initial resubmission acceptance in Q3/Q4 ..... or it may need to be after BLA is granted. Worse case, I'm going with BLA approval, which is slated for as late as Q1 2023, since all we know about approval is that it will be between 2 and 6 months from the Q3 resubmission.

    CLBP - Since the company is still laser focused on GvHD, and validating supply chains, I think the back pain trial commencement might be done in Q4 once GvHD submission has been made, and the company is in the waiting period with less workload.

    CHF - This could turn out to be the happy ending indeed......... Why the wait FDA? They still have not responded after mesoblast supplied the full data sets to them. Are they having a dilemma of consciousness ?...... Are they considering... the AA? and when are they going to give the advise..... tomorrow, next week, next month, next quarter?..... Whenever it happens it will be a shock.

    Crohns- No new results given here, so expecting at some point before the end of Q3 to hear about the control group treatment and possibly more patient numbers. Looking at the trial design, it appears to say that the control group will be assessed at 6 months after the administration, where as the intent to treat group were assessed at numerous stages including 3 months as reported on. Oh well, we will have to wait until end of August hopefully for more fantastic results.

    https://hotcopper.com.au/threads/2022-get-your-popcorn-out.6637565/?post_id=61756779&embed=1
  • A
    Armyne
    More pain with the ASX dropping a whopping 4% today and more class actions announced against MSB/meso. Ambulance chasing and macro pain: not for the feint of heart. Good luck to holders and happy buying for those looking for discounts!
  • J
    Jeff
    If you take the current SP of $2.38 times 630….you will get LONGPUMPERS price target of $1500 …so lucky that he he is on here! Let’s hear it for that fantastic, very accurate prediction from LONGPUMPER!!!
  • S
    Steve S
    Looks like a little help from the Aussie market. That's good ,it tempers the larger drops . Almost time to pick up some shares .
  • H
    Hipsterkicks
    I sure hope they are being honest and fully informed when they say they have addressed all of the FDAs manufacturing concerns. I pray this doesn't turn out like ATHX.
  • J
    Josephine
    MESO 2.49/.6944 = .717 MSB
  • A
    Armyne
    Real talk: there seems to be some chat on the likelihood of AA potential for CHF. My stance has always conservatively been that this won't be the case and there will be another trial (probably in a similar vein to CLBP progress). But of course as a biased investor I can't help but wonder how likely this is and what this would look like.

    Dr Perin says he knows how he wants to conduct the next trial (apologies I don't recall the link to that quote, I'm sure somebody will know and would hope they respond with the link to that quote). So my first thought on that is: If approved for AA, how do you get patients to agree to be a part of the trial as a potential placebo arm, when AA means they could get the treatment without the risk of getting the placebo arm? (Costs aside), or do we think that he intends to conduct a trial on patients outside of the cohort of patients who have been approved via the AA (i.e. class 2/3 diabetics/ischemics ?). Or perhaps the trial won't have a placebo arm in this instance for this reason?

    Keen to hear people's thoughts on this: I am aware that the impact on mortality and cardiac events is certainly head and shoulders above many treatments, and that the FDA has flagged cardiac events and mortality as a clinically meaningful endpoint (over hospitalisations), but I am curious about the likelihood of actually getting AA and the logistics of that with a new trial. Would certainly be a nice win for the holders, but my money is still on agvhd getting the green light first.
  • t
    tim
  • L
    LongStock
    Quarterly overview just finished. I for one will comtinue to hold for the commercialization of remestemcel-L.

    The charts all continue to show that all their products work and are very powerful. They are being very cautious about "getting it right" before handing it over to the FDA.

    Meanwhile mangement is being very resposible with finances by reducing the burn rate. Japan revenue is up 30% and they are learning a lot from Japan's launch that will apply to the USA market.

    As soon as Reme-L is approved for children they are going to launch a trial for GvHD adults and "all cause ARDS". Japan is already aprroved for both children and adults with sr-GvHD.

    One approval will set the stage for the other indications, IBD, Crohn's, ARDS, CHF (heart), Chronic Back Pain (CBP) and any high inflammatory condition.
  • G
    Gary
    stem cells ...so much promise ... but approval so difficult ...
  • v
    vasav963
    I have tried 3 times to post and Yahoo keeps deleting probably because Imention my opinions on the FDA.

    Anyway, quick question for the longtimers. I have been around since the OSIR days and waiting, waiting, waiting....

    Still a matter of when and not if for me, but worried about the potential need for cash if this goes much longer.

    Thinking of adding more and averaging down. I am just thinking that MESO may need to pull a financing lever that could hurt current shareholders.

    Any thoughts from those longtimers who are much smarter than me of when they could need more cash and the most likely lever?

    As always, GLTA....
  • p
    pearlswig
    Total Government control over anything gums up the works. They will be charging tolls to get in the front door.